Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
NCT Number: NCT06768853
Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430071, China
Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. Investigators will randomly divide all enrolled patients into an experimental group and a control group. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators will calculate the consistency between preoperative prediction results and postoperative pathological results to verify the accuracy of the model. And investigators will evaluate the impact of this new lymph node dissection method on prognosis by comparing the intraoperative blood loss, postoperative complications, disease-free survival, and overall survival between the two groups of patients. Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .
During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.
Time frame: 1 week after surgery
Compare postoperative lymph node pathology results with preoperative prediction results
Time frame: 30 days after surgery
Observation of complications within 30 days after surgery
Time frame: 2 years after surgery
Observe for recurrence within 2 years after surgery
Time frame: 2 years after surgery
Follow up after surgery to determine if there is any recurrence or metastasis, and calculate disease-free survival
Time frame: 2 years after surgery
Follow up after surgery to determine if there is death, and calculate overall survival
Time frame: During the surgery
Record intraoperative blood loss
Time frame: 2 weeks after surgery
Record postoperative drainage volume
Time frame: 2 weeks after surgery
Record the time from the end of the surgery to the removal of the drain tube
Contact information is provided by the study sponsor or research team.
Zhongnan Hospital
Other
Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics
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